Relationship between industry, FDA is strained, PwC report finds

By Michael Johnsen

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

“Consumers want safer, more effective drugs and devices, and access to the latest medical innovation,” stated Michael Mentesana, PwC’s U.S. Pharmaceutical and Life Sciences Research and Development Advisory Services leader. “Industry wants fast and efficient product approvals. And Congress wants better quality, lower cost health care that demonstrates enhanced economic and clinical value,” he said. “Hope lies in accelerating scientific and technological advancement as we learn more about genetic differences and individual responses to treatments. But the promise of faster product development has yet to be realized, and the quality and productivity of the FDA-industry relationship would be better on both sides if there was more collaboration and clarity around expectations.”

The study found that life sciences companies feel communication with the FDA has improved steadily since passage of the FDA Modernization Act of 1997, but new expectations are fueling frustration with the regulatory review process.

According to the report, the industry feels that the FDA is not keeping up with rapidly advancing technology — only 8% of drug and device makers think the FDA is doing enough to advance personalized medicine. And more than half (56%) of respondents who are familiar with the FDA’s Critical Path Initiative to bring innovative, high-priority therapies to market quickly think that the FDA currently lacks the capability to implement that initiative.

Only 38% of life sciences companies in the study said they feel that the overall working relationship with the FDA has improved over the past two years, though 80% reported that the FDA is providing better guidance about its expectations.

More than half of companies (64%) said that meeting with the FDA before submitting review materials improved the quality of their applications, and 87% said it expedited their applications. But the industry has not always taken advantage of the meetings and only about half (53%) said the FDA consistently encouraged these meetings.

Six-in-10 companies expressed frustration that the FDA had changed its position during a review, and 4-in-10 feel that some products were denied because of the FDA’s inadequate review resources.

The latest in a series of PwC reports over the past 15 years on the working relationship between the life sciences industry and the FDA, the report provides feedback from 50 life sciences companies, including the makers of biologics, drugs, medical devices and diagnostics.

The PwC report also suggested that the lay public has several misconceptions around drug development.